DeviceClearance

Product code EXB— Gastroenterology, Urology

UNITED SKIN BARRIERS

Classification name
Collector, Ostomy
Device class
Class 1
Regulation
21 CFR 876.5900
Advisory panel
Gastroenterology, Urology
Total cleared
102
First cleared
Most recent

Market context for product code EXB

FDA has cleared 102 devices under product code EXB between 1976 and 2025, filed by 36 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code EXB

Adverse events under product code EXB

product code EXB
Injury
145
Total
145

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code EXB

1–100 of 102

Data sourced from openFDA. This site is unofficial and independent of the FDA.